FDA.report

Mouthseal, Disposable, White Thermoplastic IPPB

Primary DI
00817081024296
Brand
Mouthseal, Disposable, White Thermoplastic IPPB
Company
A-M SYSTEMS, LLC
Model
Mouthseal, White Thermoplastic IPPB - 165400
Catalog number
165400
Device description
Mouthseal, Disposable, White Thermoplastic IPPB
Published
2020-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYPMouthpiece, Breathing

Product Code Classifications

CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817081024296PackageGS150In Commercial Distribution
00817081024289PrimaryGS10

GMDN Terms

TermDefinition
Breathing mouthpiece, single-useA device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags

DUNS number
020275145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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